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在多发性硬化症患者中进行现场与远程康复的李·西尔弗曼嗓音治疗-大声法:一项非劣效性试点随机对照试验的可行性证据

Delivering the Lee Silverman voice treatment-loud method in-site versus telerehabilitation in people with multiple sclerosis: Feasibility evidence of a non-inferiority pilot randomized controlled trial.

作者信息

Vitali Chiara, Fusari Giulia, Cacciatore Diego Michael, Smecca Giulia, Baldanzi Cinzia, Carullo Alessio, Rovaris Marco, Cattaneo Davide, Baglio Francesca, Isernia Sara

机构信息

IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan, Italy.

Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.

出版信息

Digit Health. 2025 May 25;11:20552076251326222. doi: 10.1177/20552076251326222. eCollection 2025 Jan-Dec.

Abstract

OBJECTIVE

Telerehabilitation may overcome accessibility barriers related to the Lee Silverman Voice Treatment (LSVT)-Loud for dysphonia rehabilitation in multiple sclerosis (MS). The present study provides the feasibility evidence on patient-relevant structural and procedure effects of a pilot randomized controlled trial comparing LSVT-Loud telerehabilitation (Tele-LSVT-Loud) versus standard delivery.

METHODS

Twenty-one people with MS (six males) with dysphonia were 1:1 randomly allocated to 4 weeks of LSVT-Loud in-site or Tele-LSVT-Loud at home accessing a telemedicine platform. The feasibility of Tele-LSVT-Loud compared to LSVT-Loud was evaluated considering adherence rate, safety (adverse events), technology interaction (User Experience Questionnaire), intrinsic motivation to the treatment (Intrinsic Motivation Inventory), and perceived rehabilitation experience (individual qualitative interviews) during and after the intervention program.

RESULTS

Thirty-one percent of eligible subjects were unavailable to follow in-site treatment. Drops-outs were higher in the LSVT-Loud than Tele-LSVT-Loud group (4 versus 1). Also, the adherence rate of synchronous sessions was 68.75% in the LSVT-Loud compared to 87.5% in the Tele-LSVT-Loud group, related to greater difficulty in integrating the treatment into a daily routine, as mentioned in the qualitative interview. No relevant adverse events were observed in both groups. The user experience with technology in the Tele-LSVT-Loud group was positive. The interviews revealed a positive therapeutic alliance, regardless of the delivery path. Interestingly, only people in the Tele-LSVT-Loud group judged equivalent the therapist-user relationship in in-site and telerehabilitation settings.

CONCLUSIONS

Telerehabilitation promotes the feasibility of LSVT-Loud. The modality of delivery is a relevant factor in determining eligibility and adherence to a voice rehabilitation program in MS.

摘要

目的

远程康复可能克服与李·西尔弗曼嗓音治疗(LSVT)-大声疗法相关的可及性障碍,该疗法用于多发性硬化症(MS)的发声障碍康复。本研究提供了一项初步随机对照试验的可行性证据,该试验比较了LSVT-大声疗法远程康复(远程LSVT-大声疗法)与标准治疗方式对患者相关结构和程序的影响。

方法

21名患有发声障碍的MS患者(6名男性)按1:1随机分配,一组在现场接受为期4周的LSVT-大声疗法,另一组在家中通过远程医疗平台接受远程LSVT-大声疗法。通过干预计划期间及之后的依从率、安全性(不良事件)、技术交互(用户体验问卷)、治疗内在动机(内在动机量表)以及感知康复体验(个人定性访谈),评估远程LSVT-大声疗法与LSVT-大声疗法相比的可行性。

结果

31%的符合条件受试者无法接受现场治疗。LSVT-大声疗法组的退出率高于远程LSVT-大声疗法组(分别为4例和1例)。此外,定性访谈中提到,LSVT-大声疗法同步治疗课程的依从率为68.75%,而远程LSVT-大声疗法组为87.5%,这与将治疗融入日常生活的难度更大有关。两组均未观察到相关不良事件。远程LSVT-大声疗法组对技术的用户体验为积极。访谈显示,无论治疗方式如何,治疗联盟都是积极的。有趣的是,只有远程LSVT-大声疗法组认为现场和远程康复环境中的治疗师-用户关系相当。

结论

远程康复提高了LSVT-大声疗法的可行性。治疗方式是决定MS患者参与嗓音康复计划的资格和依从性的一个相关因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/155d/12107005/32c13c55cf7d/10.1177_20552076251326222-fig1.jpg

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